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Compounding in ophthalmology

Compounded pharmaceuticals can be another tool at the doctor’s disposal.

By Sharon Richardson, COT, OSA

Compounding is the creation of a pharmaceutical property by a licensed pharmacist. A physician might prescribe a compounded pharmaceutical for a number of reasons. The doctor may want to customize a strength, dose, or formulation of a drop, exclude an unwanted ingredient such as a preservative, or prescribe a drug that is no longer available or is in shortage.

Most compounding is done in a pharmacy that has specific equipment and training to do so safely. These facilities come in two categories: 503A and 503B. Smaller 503A compounding pharmacies are not required to register with the FDA but can only compound with a prescription for a patient. Outsourcing facilities, also known as 503B, can provide bulk amounts of a compounded drug without an individual prescription. These facilities follow the same guidelines pharmaceutical companies follow for the manufacturing of the FDA-approved drugs. While the facilities are regulated by the FDA, compounding pharmacy therapies are not subject to premarket approval requirements. And, although the compounded drugs are not FDA approved, each ingredient in the formulation of a compounded drug is FDA approved.

An ophthalmologist may choose to prescribe a compounded drop for a number of reasons, such as an aversion to a preservative found in a commercially available drop or cost to the patient. The doctor also might prescribe a compounded drop to combine multiple therapies into a single drop — for instance, in the case of a glaucoma patient who has been prescribed multiple IOP-lowering drops. This compounded combination drop can result in fewer preservatives taken in by the patient, increased compliance, and lowered cost to the patient. It’s worth noting that insurance plan coverage can also affect price, as branded drugs may receive insurance coverage where compounded pharmaceuticals do not.

Compounding pharmacies are another tool available to the ophthalmology community to meet the needs of its patients. Knowing what they are, how they work, and how they may be utilized are the first steps in helping to utilize them.

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